Which statement about risk management in medical devices is true?

• A. Risk management is optional after market approval.
• B. Risk management only addresses device functionality, not labeling.
• C. ISO 14971 should be applied only during design, not manufacturing.
• D. Risk management involves identifying, evaluating, and controlling risks across the device lifecycle.

Answer: (D)

Risk management for medical devices is a continuous process that spans the entire lifecycle of the product—from initial concept and design through manufacturing, distribution, use, maintenance, and eventual retirement. The core idea is to identify potential hazards, assess the risks they pose, and implement controls to reduce those risks to an acceptable level, then verify the controls are effective and monitor for new risks that may arise during use. This ongoing approach is outlined in ISO 14971, which covers hazard identification, risk analysis and evaluation, implementation of risk controls, assessment of residual risk, and overall risk acceptability, all while keeping an eye on post-market feedback and surveillance. Because risk management is meant to be applied across the full lifecycle, including labeling, user instructions, manufacturing controls, and post-market monitoring, the statement that risk management involves identifying, evaluating, and controlling risks across the device lifecycle is the correct one.